Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.35 g)

Inactive Ingredients

Xanthan Gum Xylitol Silicon Dioxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2020-09-01

Medication Information

Warnings and Precautions

Do not swallow.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

Dosage and Administration

For dental use only

Description

Sodium monofluorophosphate

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Silicon Dioxide, D-Sorbitol Solution, Water, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xanthan ?Gum, Peppermint Oil, Flavor, Enzymatically Modified Stevia, Citrus Paradisi (Grapefruit) Seed Extract, Raspberry Extract, Xylitol, L-Menthol, Red Cabbage Color, Lavender Oil, Chamomile Extract, Eucalyptus Extract

Section 51945-4

Section 55105-1

for dental care

Section 55106-9

Sodium monofluorophosphate

Structured Label Content

Indications and Usage (34067-9)

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

Do not swallow.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Silicon Dioxide, D-Sorbitol Solution, Water, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xanthan ?Gum, Peppermint Oil, Flavor, Enzymatically Modified Stevia, Citrus Paradisi (Grapefruit) Seed Extract, Raspberry Extract, Xylitol, L-Menthol, Red Cabbage Color, Lavender Oil, Chamomile Extract, Eucalyptus Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for dental care

Section 55106-9 (55106-9)

Sodium monofluorophosphate

Advanced Ingredient Data

[{"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.35", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.", "34068-7": "For dental use only", "34071-1": "Do not swallow. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50565-1": "KEEP OUT OF REACH OF THE CHILDREN", "51727-6": "Silicon Dioxide, D-Sorbitol Solution, Water, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xanthan ?Gum, Peppermint Oil, Flavor, Enzymatically Modified Stevia, Citrus Paradisi (Grapefruit) Seed Extract, Raspberry Extract, Xylitol, L-Menthol, Red Cabbage Color, Lavender Oil, Chamomile Extract, Eucalyptus Extract", "55105-1": "for dental care", "55106-9": "Sodium monofluorophosphate"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information